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The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

Primary Purpose

Cerebral Ischemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hypocapnic group

Normocapnic group

About this trial

This is an interventional prevention trial for Cerebral Ischemia focused on measuring Cerebral desaturation events, Cerebral oximetry, Beach chair position

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.

Exclusion Criteria:

Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.

Sites / Locations

NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Hypocapnic group

Normocapnic group

Arm Description

Patients will be ventilated to an ETCO2 of 30-32 mm Hg.

Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Outcomes

Primary Outcome Measures

Incidence of Cerebral Desaturation Events

Cerebral desaturation events were measured with near-infrared spectroscopy

Secondary Outcome Measures

Number of Patients Experiencing Nausea and Vomiting

Assessed by recovery nurses

Postanesthesia Care Unit Length of Stay (Total Time)

Full Information

NCT ID

NCT01546636

First Posted

March 2, 2012

Last Updated

September 12, 2019

Sponsor

NorthShore University HealthSystem

1. Study Identification

Unique Protocol Identification Number

NCT01546636

Brief Title

The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

Official Title

The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NorthShore University HealthSystem

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)

Detailed Description

Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Ischemia

Keywords

Cerebral desaturation events, Cerebral oximetry, Beach chair position

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hypocapnic group

Arm Type

Placebo Comparator

Arm Description

Patients will be ventilated to an ETCO2 of 30-32 mm Hg.

Arm Title

Normocapnic group

Arm Type

Active Comparator

Arm Description

Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Intervention Type

Other

Intervention Name(s)

Hypocapnic group

Intervention Description

Patients will be ventilated to an ETCO2 of 30-32 mm Hg.

Intervention Type

Other

Intervention Name(s)

Normocapnic group

Intervention Description

Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Primary Outcome Measure Information:

Title

Incidence of Cerebral Desaturation Events

Description

Cerebral desaturation events were measured with near-infrared spectroscopy

Time Frame

Intraoperative-first 2 hours

Secondary Outcome Measure Information:

Title

Number of Patients Experiencing Nausea and Vomiting

Description

Assessed by recovery nurses

Time Frame

Postanesthesia care unit-first 2 hours

Title

Postanesthesia Care Unit Length of Stay (Total Time)

Time Frame

Approximately 5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP. Exclusion Criteria: Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glenn S. Murphy, MD

Organizational Affiliation

NorthShore University HealthSystem

Official's Role

Principal Investigator

Facility Information:

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24860157

Citation

Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Levin SD, Koh JL, Parikh KN, Patel SS. Effect of ventilation on cerebral oxygenation in patients undergoing surgery in the beach chair position: a randomized controlled trial. Br J Anaesth. 2014 Oct;113(4):618-27. doi: 10.1093/bja/aeu109. Epub 2014 May 23.

Results Reference

derived

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The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

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